(83 days)
Post-traumatic joint contracture which has resulted in loss of range of motion: fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions and management of comminuted intra-articular fractures of the distal radius.
SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods, articulating and telescoping components), and connection elements (rings, plates, and posts) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
The provided text describes a 510(k) premarket notification for a Reprocessed External Fixation Device, not an AI or imaging device, therefore many of the requested fields are not applicable. The device is a reprocessed medical device, and the focus of the submission is to demonstrate its substantial equivalence to an original, legally marketed predicate device (the Smith & Nephew Original Ilizarov® External Fixation System).
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for a reprocessed medical device like this external fixation device are generally focused on demonstrating that the reprocessed device performs functionally and safely to the same standards as the original device, and that the reprocessing itself is safe and effective (e.g., proper cleaning and sterilization).
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Functional Characteristics | Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. |
| Process Validation (Cleaning) | Process validation testing was performed to validate the cleaning procedure. |
| Manufacturing Process Quality | The manufacturing process includes visual and validated functional testing of all products produced. |
| Substantial Equivalence | The Reprocessed External Fixation Devices are substantially equivalent to the Smith & Nephew Original Ilizarov® external fixation devices based upon similarities in functional design (principle of operation), materials, indications for use, and methods of construction. |
Study Details
Given that this is a 510(k) for a reprocessed non-AI medical device, the typical "study" involves engineering and process validation testing rather than large-scale clinical trials or AI performance evaluations as would be expected for a diagnostic software device.
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Sample size used for the test set and the data provenance:
- The document mentions "Representative samples of reprocessed external fixation constructs were tested." No specific numerical sample size is provided in the text.
- Data Provenance: Not explicitly stated, but implicitly from SterilMed, Inc.'s internal testing labs, likely in the USA. These tests would be prospective in the sense that they were conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device and the "ground truth" is defined by established engineering and medical device performance standards for the predicate device, not by expert interpretation of data like images. No expert consensus on performance is described beyond regulatory review.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to discrepancies in expert readings for diagnostic algorithms. For a physical device, performance is typically assessed against quantifiable engineering specifications derived from the predicate device.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This type of study is for evaluating the impact of AI on human reader performance, which doesn't apply to a reprocessed external fixation device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical, reprocessed medical device, not an algorithm. The standalone performance would refer to the device's functional integrity as tested in the lab, which was done ("Representative samples...were tested to demonstrate appropriate functional characteristics.").
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this type of device is the established functional and safety specifications of the original (predicate) device, and adherence to those specifications through engineering tests (e.g., mechanical strength, fatigue, material integrity) and process validation (e.g., cleaning efficacy, sterilization).
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is used for this type of device submission.
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K083636 (pg 1/1)
STERILMED, INC.
Sterile & Disposable Medical Devices
A.
National Endowment for Financial Education
510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 8, 2008 For Reprocessed External Fixation Devices
SUMMARY AND CERTIFICATION 11.
510(k) Summary
MAR - 2 2009
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Garrett Ahlborg11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3483Fax: 763-488-3350Email: gahlborg@sterilmed.com |
| Date Prepared: | December 8, 2008 |
| Trade Name: | Reprocessed External Fixation device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories. |
| Classification Number: | Class II, 21 CFR 888.3030 |
| Product Code: | KTT |
| PredicateDevice: | The reprocessed external fixation device is substantially equivalent to the Smith & NephewOriginal Ilizarov® External Fixation System. |
|---|---|
| DeviceDescription: | SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods,articulating and telescoping components), and connection elements (rings, plates, and posts)contained in the original manufacturer's system. Some of the components are MR safe andmade of non-magnetic materials. MR safe components are intended for use in the MRenvironment.Note: Only the non-patient contact, external frame elements are the subject of this submission,the anchorage pins and wire elements are not included in the scope of this submission |
| Intended Use: | Post-traumatic joint contracture which has resulted in loss of range of motion: fractures anddisease which generally may result in joint contractures or loss of range of motion and fracturesrequiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limblengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissuedeformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infectedfractures or nonunions and management of comminuted intra-articular fractures of the distalradius. |
| Functional andSafety Testing: | Representative samples of reprocessed external fixation constructs were tested to demonstrateappropriate functional characteristics. Process validation testing was performed to validate thecleaning procedure. In addition, the manufacturing process includes visual and validatedfunctional testing of all products produced. |
| Conclusion: | The Reprocessed External Fixation Devices are substantially equivalent to the Smith &Nephew Original Ilizarov® external fixation devices.This conclusion is based upon the devices` similarities in functional design (principle ofoperation), materials, indications for use and methods of construction. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed, Inc. % Mr. Garrett Ahlborg Regulatory Affairs Specialist 11400 73rd Ave. North #100 Maple Grove, Minnesota 55369
MAR - 2 2009
Re: K083636
Trade/Device Name: Reprocessed External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: December 8, 2008 Received: December 9, 2008
Dear Mr. Ahlborg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
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This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K083636
Device Name: Reprocessed External Fixation Device
Indications for Use:
- Post-traumatic joint contracture which has resulted in loss of range of motion. .
- Fractures and disease which generally may result in joint contractures or loss of range of motion and � fractures requiring distraction.
- Open and closed fracture fixation. .
- Pseudoarthrosis of long bones. �
- Limb lengthening by epiphyseal or metaphyseal distraction. .
- Correction of bony or soft tissue deformities. ●
- Correction of segmental bony or soft tissue defects. .
- Joint arthrodesis.
- Infected fractures or nonunions. .
- Management of comminuted intra-articular fractures of the distal radius.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 1083631
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.